Medical Devices Regulatory Services
in Mexico

Overview

Mexico is the import hub for Medical Devices in Latin America. Medical Devices in Mexico are regulated by the Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios, COFEPRIS). The agency classifies Medical Devices into six different groups depending on their function and purpose:

  • Diagnostic Agents
  • Medical Equipment (I.E. Accessories And Appliances)
  • Prosthetics, Orthotics, And Functional Aids
  • Surgical Materials
  • Hygiene Devices
  • Dental Supplies

Regulatory Authority: COFEPRIS

Regulation: Pharmaceutical Affairs Act (PAA) & Regulation for registration of Medical Devices

Regulatory Pathway: Device Registration

Authorized Representative: Sanitary Responsible Person (SRP)

QMS Requirement:  Quality System Documentation (QSD) ISO 13485

Assessment of Technical Data:  COFEPRIS

Validity of License: 5 years

Submission Format: Paper

Language: English & Spanish

Mexico Medical Device Classification

COFEPRIS classifies devices into Class I, II and III based on 20 rules framed by Health Products Technical Committee. The rules intended for Medical Device Regulation in Mexico are very broad needing extensive understanding. The basis for classification is ambiguous to decode and the challenges pertaining to linguistic translations are also prevalent. After device are placed in their groups, they are categorized into four different classes depending on their risk: Low Risk, Class I, Class II, Class III. Class I Medical Devices are associated with the lowest risk, while Class III Medical Devices are associated with the highest risk.

Sanitary Responsible Person (SRP)

Foreign manufacturers should appoint a Sanitary Responsible Person (SRP) as a pre-requisite to market devices in Mexico. Foreign manufacturers may appoint their distributors or importers as SRP. The SRP shall, however provide required flexibility to appoint multiple distributors in Mexico.

Mexico Medical Device Registration

The manufacturers may opt for any of the three pathways for device registration - Traditional pathway, Equivalence pathway, and/or Third-Party review of devices.

Class I devices do not require to undergo detailed device review process and a simple notification would suffice to market the device in Mexico.

Class II and Class III Devices with approval in reference countries such as, the U.S., Canada or Japan qualify for  Equivalency Review process. Devices without these approvals shall undergo standard Review process. Applicants may opt to go through the Third-Party Review (TPR), which is faster at the cost of additional expenses payable to such accredited Third-Party.

Process flow

Post Approval Device Life Cycle Management

Freyr supports the foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing medical device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of approvals and registration through timely payment of administrative and registration fees
  • Renewal of licenses
  • Liaising between the COFEPRIS and the manufacturer

 

Summary

Class

Registration Pathway

Timelines

I

QMS + Product Registration

1-3 months

II

QMS + Product Registration

10 months - 1 years

III

QMS + Product Registration

10 months - 1 years

Expertise

Freyr Expertise

  • Regulatory Due Diligence
  • Official Classification 
  • Notice of Operation support
  • Device Registration 
  • Sanitary Responsible Person (SRP) 
  • Labeling support
  • Translation support
  • Distributor identification and qualification 
  • Post Marketing Surveillance 
  • Post Approval Change Management
  • License renewal and transfer 
  • Submission and liaison with The COFEPRIS